Beijing – October 12, 2026 -- T-MAXIMUM PHARMACEUTICAL has received FDA clearance to start a Phase 2 study of MT027, its B7-H3-targeted allogeneic CAR-T therapy, in patients with brain metastases from lung and breast cancer. It is the second Phase 2 program for the asset to clear the agency.
MT027 now has two FDA-cleared Phase 2 programs in intracranial solid tumors
The FDA previously cleared a Phase 2 study of MT027 in recurrent glioblastoma. The therapy holds Orphan Drug Designation and Fast Track Designation. The two programs give T-MAXIMUM a dual-indication portfolio covering both primary and metastatic intracranial solid tumors.
Early data in lung cancer brain metastases showed 2 partial responses among 3 evaluable patients
Data presented at the IASLC 2026 World Conference on Lung Cancer covered five heavily pretreated patients with refractory brain metastases from lung cancer. All five had no guideline-recommended subsequent treatment options and completed treatment. Two of the three evaluable patients had partial responses. No Grade 3 or higher adverse events and no graft-versus-host disease were reported.
The company also cited an investigator-initiated trial of MT026, a program built on the same platform, published in Nature Communications in 2026. Among 5 patients with recurrent high-grade glioma, investigators observed 1 complete response and 3 partial responses, an objective response rate of 80%. No treatment-related Grade 3 or higher adverse events occurred. T-MAXIMUM cautions that early results from small patient numbers may not predict outcomes in larger studies.
Non-viral gene editing departs from the lentiviral vector approach common in the industry
MT027 is made with a fully non-viral gene-editing process and is delivered locally into the brain. T-MAXIMUM says the process offers potential advantages in product safety, batch-to-batch consistency and cost control. The manufacturing process was locked before the product entered Phase 2 development.
Brain metastases affect about 20% of cancer patients, with a large addressable population
International studies cited by the company estimate that about 20% of cancer patients develop brain metastases, rising to 20% to 40% among those with advanced solid tumors. In the United States, an estimated 200,000 to 300,000 patients are newly diagnosed each year. In 2022, global cancer incidence reached nearly 20 million new cases, including nearly 2.5 million lung cancer cases and about 2.3 million female breast cancer cases. Both are leading primary tumors behind brain metastases.
The company says treating intracranial lesions remains constrained by the blood-brain barrier, tumor heterogeneity and the need to preserve neurological function. This is especially true for patients who progress intracranially after prior therapy.
T-MAXIMUM management said it will continue to evaluate MT027's safety and clinical value through well-designed studies while advancing product supply, clinical execution and key data generation.